Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

Czasopismo : Acta Chromatographica
Tytuł artykułu : Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

Autorzy :
Sajewicz, M.
University of Silesia Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Kowalska, T.
University of Silesia Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland, teresa.kowalska@us.edu.pl,
Szalka, M.
ICN Polfa Rzeszów S.A. Product Development Department 35-959 Rzeszów Poland,
Kostka, J.
Rzeszów University of Technology Department of Chemical and Process Engineering 35-959 Rzeszów,
Rokaszewski, E.
ICN Polfa Rzeszów S.A. Product Development Department 35-959 Rzeszów Poland,
Kaczmarski, K.
Rzeszów University of Technology Department of Chemical and Process Engineering 35-959 Rzeszów, kkaczmarski@prz.edu.pl,
Belal, F.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
El-Brashy, A. M.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
El-Enany, N.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
Tolba, M. M.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
Cielecka-Piontek, J.
Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland, jpiontek@ump.edu.pl,
Krause, A.
PozLab Contract Research Organization Poznań Poland,
Zalewski, P.
Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland,
Lunzer, A.
Tanaka Laboratory in Hokkaido University W 7, Kita-ku Sapporo 060-8638 Japan,
Jelińska, A.
Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland,
Abstrakty : A stability-indicating LC assay method was developed and validated for the quantitative determination of doripenem and biapenem in pharmaceutical dosage forms in the presence of degradation products formed during forced degradation studies. An isocratic RP-HPLC method was developed with a C-18 (250 mm × 4.6 mm, 5 μm) column and 12 mM ammonium acetate-acetonitrile (96:4 υ/υ) as mobile phase. The flow rate of the mobile phase was 1.0 mL min-1for doripenem and biapenem. The determination was carried out at the wavelength of 295 nm. The carbapenems were subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, photolysis, and thermal degradation. The developed method was validated with respect to linearity, accuracy, precision, selectivity, and robustness.

Słowa kluczowe : method validation, stability-indicating method, doripenem, biapenem,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2012
Numer : Vol. 24, no. 2
Strony : 207 – 219
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DOI :
Cytuj : Sajewicz, M. ,Kowalska, T. ,Szalka, M. ,Kostka, J. ,Rokaszewski, E. ,Kaczmarski, K. ,Belal, F. ,El-Brashy, A. M. ,El-Enany, N. ,Tolba, M. M. ,Cielecka-Piontek, J. ,Krause, A. ,Zalewski, P. ,Lunzer, A. ,Jelińska, A. , Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms. Acta Chromatographica Vol. 24, no. 2/2012
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